Needle insertion systems and methods

ABSTRACT

A housing may have a needle, plunger, and bias mechanism supported within the housing by a tab configured to retain the plunger in position and to allow the plunger to move under bias force imparted by the bias mechanism to move the needle to an insert position when the tab is removed. A base and a structure may be configured for relative movement there between and may be adapted to be secured to a user with a cannula extending through a body of the structure into the user during use of a medical device. A housing may be adapted to be secured to a user to support a medical device operable with an insertion needle, the housing having a magnifying material for increasing visibility of an injection site.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application is a Divisional of U.S. application Ser. No.12/336,367, filed Dec. 16, 2008, incorporated herein by reference in itsentirety.

BACKGROUND OF THE INVENTION

Certain chronic diseases may be treated, according to modern medicaltechniques, by delivering a medication or other substance to auser-patient's body, either in a continuous manner or at particulartimes or time intervals within an overall time period. For example,diabetes is a chronic disease that is commonly treated by deliveringdefined amounts of insulin to the user-patient at appropriate times.Some common modes of providing an insulin therapy to a user-patientinclude delivery of insulin through manually operated syringes andinsulin pens. Other modern systems employ programmable pumps to delivercontrolled amounts of insulin to a user-patient.

Pump type delivery devices have been configured in external devices(that connect to a user-patient) or implantable devices (to be implantedinside of a user-patient's body). External pump type delivery devicesinclude devices designed for use in a generally stationary location (forexample, in a hospital or clinic), and further devices configured forambulatory or portable use (to be carried by a user-patient). Examplesof some external pump type delivery devices are described in U.S. patentapplication Ser. No. 11/211,095, filed Aug. 23, 2005, titled “InfusionDevice And Method With Disposable Portion” and Published PCT ApplicationWO 01/70307 (PCT/US01/09139) titled “Exchangeable Electronic Cards ForInfusion Devices” (each of which is owned by the assignee of the presentinvention), Published PCT Application WO 04/030716 (PCT/US2003/028769)titled “Components And Methods For Patient Infusion Device,” PublishedPCT Application WO 04/030717 (PCT/US2003/029019) titled “DispenserComponents And Methods For Infusion Device,” U.S. Patent ApplicationPublication No. 2005/0065760 titled “Method For Advising PatientsConcerning Doses Of Insulin,” and U.S. Pat. No. 6,589,229 titled“Wearable Self-Contained Drug Infusion Device,” each of which isincorporated herein by reference in its entirety.

External pump type delivery devices may be connected in fluid-flowcommunication to a user-patient, for example, through a suitable hollowtubing. The hollow tubing may be connected to a hollow needle that isdesigned to pierce the user-patient's skin and deliver an infusionmedium to the user-patient. Alternatively, the hollow tubing may beconnected directly to the user-patient as or through a cannula or set ofmicro-needles.

In contexts in which the hollow tubing is connected to the user-patientthrough a hollow needle that pierces the user-patient's skin, a manualinsertion of the needle into the user-patient can be somewhat traumaticto the user-patient. Accordingly, insertion mechanisms have been made toassist the insertion of a needle into the user-patient, whereby a needleis forced by a spring to quickly move from a retracted position into anextended position. As the needle is moved into the extended position,the needle is quickly forced through the user-patient's skin in asingle, relatively abrupt motion that can be less traumatic to certainuser-patients as compared to a slower, manual insertion of a needle.While a quick thrust of the needle into the user-patient's skin may beless traumatic to some patients than a manual insertion, it is believedthat, in some contexts, some patients may feel less trauma if the needleis moved a very slow, steady pace. Examples of insertion mechanisms thatmay be used with and may be built into a delivery device are describedin: U.S. patent application Ser. No. 11/645,435, filed Dec. 26, 2006,titled “Infusion Medium Delivery system, Device And Method With NeedleInserter And Needle Inserter Device And Method,”; and U.S. patentapplication Ser. No. 11/211,095, filed Aug. 23, 2005, titled “InfusionDevice And Method With Disposable Portion” (each of which is assigned tothe assignee of the present invention), each of which is incorporatedherein by reference in its entirety. Other examples of insertion toolsare described in U.S. Patent Application Publication No. 2002/0022855,titled “Insertion Device For An Insertion Set And Method Of Using TheSame” (assigned to the assignee of the present invention), which isincorporated herein by reference in its entirety. Other examples ofneedle/cannula insertion tools that may be used (or modified for use) toinsert a needle and/or cannula, are described in, for example U.S.patent application Ser. No. 10/389,132 filed Mar. 14, 2003, and entitled“Auto Insertion Device For Silhouette Or Similar Products,” and/or U.S.patent application Ser. No. 10/314,653 filed Dec. 9, 2002, and entitled“Insertion Device For Insertion Set and Method of Using the Same,” bothof which are incorporated herein by reference in their entirety.

As compared to syringes and insulin pens, pump type delivery devices canbe significantly more convenient to a user-patient, in that accuratedoses of insulin may be calculated and delivered automatically to auser-patient at any time during the day or night. Furthermore, when usedin conjunction with glucose sensors or monitors, insulin pumps may beautomatically controlled to provide appropriate doses of infusion mediumat appropriate times of need, based on sensed or monitored levels ofblood glucose.

Pump type delivery devices have become an important aspect of modernmedical treatments of various types of medical conditions, such asdiabetes. As pump technologies improve and as doctors and user-patientsbecome more familiar with such devices, the popularity of externalmedical infusion pump treatment increases and is expected to increasesubstantially over the next decade.

SUMMARY OF THE DISCLOSURE

Various embodiments of the present invention are directed toneedle-inserting devices and medical devices systems and methods. Aneedle-inserting device in accordance with an embodiment of the presentinvention may include, but is not limited to, a housing, a plunger, abias mechanism, and a needle. The housing may have an internal chamberand a longitudinal dimension. The plunger may be arranged for movementwithin the internal chamber, in the direction of the longitudinaldimension of the housing, from a first plunger position to a secondplunger position. The bias mechanism may be for imparting a bias forceon the plunger when the plunger is in the first plunger position. Thebias force may be directed toward the second plunger position. Theneedle may be connected to the plunger for movement with the plunger.

The plunger may have a tab end configured to retain the plunger in thefirst plunger position. The tab end may be moveable relative to thehousing. Upon movement of the tab end, the plunger may be free to movefrom the first plunger position to the second plunger position under thebias force imparted by the bias mechanism to move the needle to aninsert position.

In various embodiments, the tab end may be removable from the plunger.Upon removal of the tab end from the plunger, the plunger may be free tomove from the first plunger position to the second plunger positionunder the bias force imparted by the bias mechanism to move the needleto an insert position.

In various embodiments, the tab end may be located at least partiallyoutside the internal chamber of the housing. In other embodiments, thetab end may be configured to be broken off the plunger head. In someembodiments, the tab end may be configured to be disconnected from theplunger head. In other embodiments, the tab end may be configured to betwisted off the plunger head.

In various embodiments, the housing may have an opening that opens tothe internal chamber, the opening having a width dimension. The tab endmay have a width dimension larger than the width dimension of theopening. In some embodiments, the tab end may be configured to be one ofrotatable and twistable to fit within the opening of the housing. Inother embodiments, the tab end may be configured to be compressible tofit within the opening of the housing.

In various embodiments, at least a portion of the needle may pierce skinof a user as the plunger moves from the first plunger position to thesecond plunger position to move the needle to the insert position.

In various embodiments, the device may further include a hollow cannulahaving a hollow interior and arranged with the needle extending throughthe hollow interior. Upon movement of the tab end, the plunger may befree to move from the first plunger position to the second plungerposition under the bias force imparted by the bias mechanism to move thehollow cannula to a cannula insert position. In some embodiments, atleast a portion of the cannula may pierce skin of a user as the plungermoves from the first plunger position to the second plunger position tomove the cannula to the insert position.

In various embodiments, the device may further include an insertstructure arranged for movement within the internal chamber of thehousing with movement of the plunger from the first plunger position tothe second plunger position. The insert structure may include a bodythrough which the needle extends. The housing may have at least one slotor groove. The body of the insert structure may include a shaped portionconfigured to engage the at least one slot or groove upon the insertstructure being moved as the plunger moves from the first plungerposition to the second plunger position.

In some embodiments, the housing may have a flexible portion near or inthe vicinity of the at least one slot or groove. The body of the insertstructure may be arranged to engage and outwardly flex the flexibleportion of the housing upon the insert structure being moved as theplunger moves from the first plunger position to the second plungerposition.

In various embodiments, the device may further include an insertstructure may be arranged for movement within the internal chamber ofthe housing with movement of the plunger from the first plunger positionto the second plunger position. The insert structure may include a bodythrough which the needle extends. The insert structure may have a fluidchannel. The fluid channel may be connectable to a reservoir when theinsert structure moves with the plunger from the first plunger positionto the second plunger position.

In further embodiments, the device may include a hollow cannula having ahollow interior and arranged with the needle extending through thehollow interior. Upon movement of the tab end, the plunger may be freeto move from the first plunger position to the second plunger positionunder the bias force imparted by the bias mechanism to move the hollowcannula to an insert position. The fluid channel may be in fluidcommunication with the hollow interior of the cannula upon the insertstructure being moved with the plunger from the first plunger positionto the second plunger position.

A method of making a needle-inserting device in accordance with anembodiment of the present invention may include, but is not limited toany one or combination of, (i) providing a housing having an internalchamber and a longitudinal dimension; (ii) arranging a plunger formovement within the internal chamber, in the direction of thelongitudinal dimension of the housing, from a first plunger position toa second plunger position; (iii) providing a bias mechanism forimparting a bias force on the plunger when the plunger is in the firstplunger position, wherein the bias force is directed toward the secondplunger position; (iv) locating a needle connected to the plunger, formovement with the plunger; and (v) configuring a tab end of the plungerto retain the plunger in the first plunger position, the tab endmoveable relative to the housing such that upon movement of the tab end,the plunger is free to move from the first plunger position to thesecond plunger position under the bias force imparted by the biasmechanism to move the needle to an insert position.

A medical device in accordance with an embodiment of the presentinvention may include, but is not limited to, a medical monitoring ortreatment device, a base, a structure, and a cannula. The medicalmonitoring or treatment device may be configured to provide a monitoringor treatment operation on a user. The base may be adapted to be securedto the user during operation of the medical monitoring or treatmentdevice. The structure may be adapted to be secured to the user duringoperation of the medical monitoring or treatment device. The structuremay be connected to and supported by the base. The structure may have abody. The structure and the base may be configured for relative movementthere between. The cannula may extend through the body of the structureduring operation of the medical monitoring or treatment device. Thecannula may be for inserting into the user during operation of themedical monitoring or treatment device.

In various embodiments, the structure may be arranged to be separate andapart from the base. In various embodiments, the structure may beoperatively connected to the base.

In various embodiments, the device may further include a flexibleconnection that may be for connecting the base and the structure. Insome embodiments, at least one of the base, the structure, and thecannula may be placeable by an insertion device. The flexible connectionmay be adapted to release the insertion device after placement of the atleast one of the base, the structure, and the cannula. In someembodiments, the flexible connection may comprise a living hingeconnecting the base and the structure.

In various embodiments, the device may further include a bias memberprovided between the base and the structure. In various embodiments, thedevice may further include a fluid connection in fluid communicationwith the cannula and a reservoir containing fluidic media. In some Invarious embodiments, the device may further include a housing. The baseand the structure may be adapted to fit within the housing.

In various embodiments, the base may have an interior chamber. Thecannula may be supported within the interior chamber of the base. Invarious embodiments, the base may have an interior chamber. Thestructure may be supported within the interior chamber of the base.

In various embodiments, the base may have a base surface facing skin ofthe user during operation of the medical monitoring or treatment device.The base may have an opening through the base surface. The structure maybe supported at least partially within the opening.

In some embodiments, the structure may have an inserting surface facingskin of the user during operation of the medical monitoring or treatmentdevice. An adhesive material may be provided on at least a portion ofthe base surface and at least a portion of the inserting surface forsecuring the at least one of the base and the structure to the user. Theadhesive material may have a different adhesion strength on thestructure than on the base.

In various embodiments, the device may further include an adhesivematerial provided on at least a portion of the structure and at least aportion of the base for securing the at least one of the base and thestructure to the user. The adhesive material may have a differentadhesion strength on the structure than on the base.

In various embodiments, the device may further include an adhesivematerial provided on at least a first portion of the structure and atleast a second portion of the structure for securing the structure tothe user. The adhesive material may have a different adhesion strengthon the first portion than on the second portion.

In various embodiments, the device may further include an adhesivematerial provided on at least a first portion of the base and at least asecond portion of the base for securing the base to the user. Theadhesive material may have a different adhesion strength on the firstportion than on the second portion.

In various embodiments, at least one of the base, the structure, and thecannula may be placeable by an insertion device. In various embodiments,the structure may comprise a sensor for sensing a parameter of the userduring operation of the medical monitoring or treatment device.

In various embodiments, the device may include a sensor that may be forsensing a parameter of the user during operation of the medicalmonitoring or treatment device. The sensor may be operatively connectedto and supported by the structure.

A method of making a medical device in accordance with an embodiment ofthe present invention may include, but is not limited to any one orcombination of, (i) providing a medical monitoring or treatment deviceconfigured to provide a monitoring or treatment operation on a user;(ii) providing a base adapted to be secured to the user during operationof the medical monitoring or treatment device; (iii) providing astructure adapted to be secured to the user during operation of themedical monitoring or treatment device, the structure connected to andsupported by the base, the structure having a body, the structure andthe base configured for relative movement there between; and (iv)providing a cannula extending through the body of the structure duringoperation of the medical monitoring or treatment device, the cannula forinserting into the user during operation of the medical monitoring ortreatment device.

A medical device in accordance with an embodiment of the presentinvention may include, but is not limited to, a medical monitoring ortreatment device, a housing, and a magnifying material. The medicalmonitoring or treatment device may be configured to provide a monitoringor treatment operation on a user. The medical monitoring or treatmentdevice may be operable with an insertion needle. The housing may beadapted to be secured to the user for supporting the medical monitoringor treatment device during operation of the medical monitoring ortreatment device. The magnifying material may be arranged on the housingfor increasing visibility of an injection site on skin of the user whenpiercing the skin of the user with the insertion needle.

In various embodiments, the housing may have an opening for inserting atleast a portion of the insertion needle. The opening may be in verticalalignment with the injection site.

In various embodiments, the housing may have an opening for inserting atleast a portion of the insertion needle. The opening may be disalignedwith the injection site.

In various embodiments, at least a portion of the magnifying area may belocated above the injection site. In various embodiments, the magnifyingarea may be laterally offset to the injection site.

A method of making a medical device in accordance with an embodiment ofthe present invention may include, but is not limited to any one orcombination of, (i) providing a medical monitoring or treatment deviceconfigured to provide a monitoring or treatment operation on a user, themedical monitoring or treatment device operable with an insertionneedle; (ii) providing a housing adapted to be secured to the user forsupporting the medical monitoring or treatment device during operationof the medical monitoring or treatment device; and (iii) arranging amagnifying material on the housing for increasing visibility of aninjection site on skin of the user when piercing the skin of the userwith the insertion needle.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a generalized representation of a system inaccordance with an embodiment of the present invention;

FIG. 2 illustrates an example of a system in accordance with anembodiment of the present invention;

FIG. 3 illustrates an example of a delivery device in accordance with anembodiment of the present invention;

FIG. 4 illustrates a delivery device in accordance with an embodiment ofthe present invention;

FIG. 5A illustrates a durable portion of a delivery device in accordancewith an embodiment of the present invention;

FIG. 5B illustrates a section view of a durable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 5C illustrates a section view of a durable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 6A illustrates a disposable portion of a delivery device inaccordance with an embodiment of the present invention;

FIG. 6B illustrates a section view of a disposable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 6C illustrates a section view of a disposable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 7 illustrates portions of a medical device in accordance with anembodiment of the present invention;

FIG. 8 illustrates a medical device in accordance with an embodiment ofthe present invention;

FIG. 9 illustrates a medical device in accordance with an embodiment ofthe present invention;

FIG. 10 illustrates a medical device in accordance with an embodiment ofthe present invention;

FIG. 11 illustrates a medical device in accordance with an embodiment ofthe present invention;

FIG. 12 illustrates a medical device in accordance with an embodiment ofthe present invention;

FIG. 13 illustrates a medical device in accordance with an embodiment ofthe present invention;

FIG. 14 illustrates a medical device in accordance with an embodiment ofthe present invention;

FIG. 15 illustrates a medical device in accordance with an embodiment ofthe present invention;

FIG. 16 illustrates cross-section of a needle-inserting device inaccordance with an embodiment of the present invention;

FIG. 17 illustrates a cross-section of a needle-inserting device inaccordance with an embodiment of the present invention;

FIG. 18A illustrates a cross-section of a medical device in accordancewith an embodiment of the present invention;

FIG. 18B illustrates a cross-section of a medical device in accordancewith an embodiment of the present invention;

FIG. 19A illustrates a cross-section of a medical device in accordancewith an embodiment of the present invention;

FIG. 19B illustrates a cross-section of a medical device in accordancewith an embodiment of the present invention; and

FIG. 20 illustrates a cross-section of a medical device in accordancewith an embodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 illustrates a generalized representation of a system 10 inaccordance with an embodiment of the present invention. The system 10includes a delivery device 12. The system 10 may further include asensing device 14, a command control device (CCD) 16, and a computer 18.In various embodiments, the delivery device 12 and the sensing device 14may be secured at desired locations on the body 5 of a patient oruser-patient 7. The locations at which the delivery device 12 and thesensing device 14 are secured to the body 5 of the user-patient 7 inFIG. 1 are provided only as representative, non-limiting, examples.

The system 10, delivery device 12, sensing device 14, CCD 16 andcomputer 18 may be similar to those described in the following U.S.patent applications that were assigned to the assignee of the presentinvention, however, with a reservoir and plunger configuration such asdescribed herein with reference to FIGS. 7-8C, where each of followingpatent applications is incorporated herein by reference in its entirety:(i) U.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005,“Infusion Device And Method With Disposable Portion”; (ii) U.S. patentapplication Ser. No. 11/515,225, filed Sep. 1, 2006, “Infusion MediumDelivery Device And Method With Drive Device For Driving Plunger InReservoir”; (iii) U.S. patent application Ser. No. 11/588,875, filedOct. 27, 2006, “Systems And Methods Allowing For Reservoir Filling AndInfusion Medium Delivery”; (iv) U.S. patent application Ser. No.11/588,832, filed Oct. 27, 2006, “Infusion Medium Delivery Device AndMethod With Drive Device For Driving Plunger In Reservoir”; (v) U.S.patent application Ser. No. 11/588,847, filed Oct. 27, 2006, “InfusionMedium Delivery Device And Method With Compressible Or Curved ReservoirOr Conduit”; (vi) U.S. patent application Ser. No. 11/589,323, filedOct. 27, 2006, “Infusion Pumps And Methods And Delivery Devices AndMethods With Same”; (vii) U.S. patent application Ser. No. 11/602,173,filed Nov. 20, 2006, “Systems And Methods Allowing For Reservoir FillingAnd Infusion Medium Delivery”; (viii) U.S. patent application Ser. No.11/602,052, filed Nov. 20, 2006, “Systems And Methods Allowing ForReservoir Filling And Infusion Medium Delivery”; (ix) U.S. patentapplication Ser. No. 11/602,428, filed Nov. 20, 2006, “Systems AndMethods Allowing For Reservoir Filling And Infusion Medium Delivery”;(x) U.S. patent application Ser. No. 11/602,113, filed Nov. 20, 2006,“Systems And Methods Allowing For Reservoir Filling And Infusion MediumDelivery”; (xi) U.S. patent application Ser. No. 11/604,171, filed Nov.22, 2006, “Infusion Medium Delivery Device And Method With Drive DeviceFor Driving Plunger In Reservoir”; (xii) U.S. patent application Ser.No. 11/604,172, filed Nov. 22, 2006, “Infusion Medium Delivery DeviceAnd Method With Drive Device For Driving Plunger In Reservoir”; (xiii)U.S. patent application Ser. No. 11/606,703, filed Nov. 30, 2006,“Infusion Pumps And Methods And Delivery Devices And Methods With Same”;(xiv) U.S. patent application Ser. No. 11/606,836, filed Nov. 30, 2006,“Infusion Pumps And Methods And Delivery Devices And Methods With Same”;U.S. patent application Ser. No. 11/636,384, filed Dec. 8, 2006,“Infusion Medium Delivery Device And Method With Compressible Or CurvedReservoir Or Conduit”; (xv) U.S. patent application Ser. No. 11/645,993,filed Dec. 26, 2006, “Infusion Medium Delivery Device And Method WithCompressible Or Curved Reservoir Or Conduit”; U.S. patent applicationSer. No. 11/645,972, filed Dec. 26, 2006, “Infusion Medium DeliverySystem, Device And Method With Needle Inserter And Needle InserterDevice And Method”; (xvi) U.S. patent application Ser. No. 11/646,052,filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And MethodWith Needle Inserter And Needle Inserter Device And Method”; (xvii) U.S.patent application Ser. No. 11/645,435, filed Dec. 26, 2006, “InfusionMedium Delivery System, Device And Method With Needle Inserter AndNeedle Inserter Device And Method”; (xviii) U.S. patent application Ser.No. 11/646,000, filed Dec. 26, 2006, “Infusion Medium Delivery System,Device And Method With Needle Inserter And Needle Inserter Device AndMethod”; and (xix) U.S. patent application Ser. No. 11/759,725, filedJun. 7, 2007, “Infusion Medium Delivery Device And Method With DriveDevice For Driving Plunger In Reservoir”. In other embodiments, thesystem 10, delivery device 12, sensing device 14, CCD 16, and computer18 may have other suitable configurations.

The delivery device 12 is configured to deliver fluidic media to thebody 5 of the user-patient 7. In various embodiments, fluidic mediaincludes a liquid, a fluid, a gel, or the like. In some embodiments,fluidic media includes a medicine or a drug for treating a disease or amedical condition. For example, fluidic media may include insulin fortreating diabetes, or may include a drug for treating pain, cancer, apulmonary disorder, HIV, or the like. In some embodiments, fluidic mediaincludes a nutritional supplement, a dye, a tracing medium, a salinemedium, a hydration medium, or the like.

The sensing device 14 includes a sensor, a monitor, or the like, forproviding sensor data or monitor data. In various embodiments, thesensing device 14 may be configured to sense a condition of theuser-patient 7. For example, the sensing device 14 may includeelectronics and enzymes reactive to a biological condition, such as ablood glucose level, or the like, of the user-patient 7. In variousembodiments, the sensing device 14 may be secured to the body 5 of theuser-patient 7 or embedded in the body 5 of the user-patient 7 at alocation that is remote from the location at which the delivery device12 is secured to the body 5 of the user-patient 7. In various otherembodiments, the sensing device 14 may be incorporated within thedelivery device 12.

In further embodiments, the sensing device 14 and/or the delivery device12 may utilize a closed-loop system. Examples of sensing devices and/ordelivery devices utilizing closed-loop systems may be found at, but arenot limited to, the following references: (i) U.S. Pat. No. 6,088,608,entitled “Electrochemical Sensor And Integrity Tests Therefor”; (ii)U.S. Pat. No. 6,119,028, entitled “Implantable Enzyme-Based MonitoringSystems Having Improved Longevity Due To Improved Exterior Surfaces”;(iii) U.S. Pat. No. 6,589,229, entitled “Implantable Enzyme-BasedMonitoring Systems Adapted for Long Term Use”; (iv) U.S. Pat. No.6,740,072, entitled “System And Method For Providing Closed LoopInfusion Formulation Delivery”; (v) U.S. Pat. No. 6,827,702, entitled“Safety Limits For Closed-Loop Infusion Pump Control”; (vi) U.S. Pat.No. 7,323,142, entitled “Sensor Substrate And Method Of FabricatingSame”; (vii) U.S. patent application Ser. No. 09/360,342, filed Jul. 22,1999, entitled “Substrate Sensor”; and (viii) U.S. Provisional PatentApplication Ser. No. 60/318,060, filed Sep. 7, 2001, entitled “SensingApparatus and Process”, all of which are incorporated herein byreference in their entirety.

In such embodiments, the sensing device 14 may be configured to sense acondition of the user-patient 7, such as, but not limited to, bloodglucose level, or the like. The delivery device 12 may be configured todeliver fluidic media in response to the condition sensed by the sensingdevice 14. In turn, the sensing device 14 may continue to sense a newcondition of the user-patient, allowing the delivery device 12 todeliver fluidic media continuously in response to the new conditionsensed by the sensing device 14 indefinitely. In other embodiments, thesensing device 14 and/or the delivery device 12 may be configured toutilize the closed-loop system only for a portion of the day, forexample only when the user-patient is asleep or awake.

Each of the delivery device 12, the sensing device 14, the CCD 16, andthe computer 18 may include transmitter, receiver, or transceiverelectronics that allow for communication with other components of thesystem 10. The sensing device 14 may be configured to transmit sensordata or monitor data to the delivery device 12. The sensing device 14may also be configured to communicate with the CCD 16. The deliverydevice 12 may include electronics and software that are configured toanalyze sensor data and to deliver fluidic media to the body 5 of theuser-patient 7 based on the sensor data and/or preprogrammed deliveryroutines.

The CCD 16 and the computer 18 may include electronics and othercomponents configured to perform processing, delivery routine storage,and to control the delivery device 12. By including control functions inthe CCD 16 and/or the computer 18, the delivery device 12 may be madewith more simplified electronics. However, in some embodiments, thedelivery device 12 may include all control functions, and may operatewithout the CCD 16 and the computer 18. In various embodiments, the CCD16 may be a portable electronic device. In addition, in variousembodiments, the delivery device 12 and/or the sensing device 14 may beconfigured to transmit data to the CCD 16 and/or the computer 18 fordisplay or processing of the data by the CCD 16 and/or the computer 18.

Examples of the types of communications and/or control capabilities, aswell as device feature sets and/or program options may be found in thefollowing references: (i) U.S. patent application Ser. No. 10/445,477,filed May 27, 2003, entitled “External Infusion Device with RemoteProgramming, Bolus Estimator and/or Vibration Alarm Capabilities”; (ii)U.S. patent application Ser. No. 10/429,385, filed May 5, 2003, entitled“Handheld Personal Data Assistant (PDA) with a Medical Device and Methodof Using the Same”; and (iii) U.S. patent application Ser. No.09/813,660, filed Mar. 21, 2001, entitled “Control Tabs for InfusionDevices and Methods of Using the Same”, all of which are incorporatedherein by reference in their entirety.

FIG. 2 illustrates an example of the system 10 in accordance with anembodiment of the present invention. The system 10 in accordance withthe embodiment illustrated in FIG. 2 includes the delivery device 12 andthe sensing device 14. The delivery device 12 in accordance with anembodiment of the present invention includes a disposable housing 20, adurable housing 30, and a reservoir system 40. The delivery device 12may further include an infusion path 50.

Elements of the delivery device 12 that ordinarily contact the body of auser-patient or that ordinarily contact fluidic media during operationof the delivery device 12 may be considered as a disposable portion ofthe delivery device 12. For example, a disposable portion of thedelivery device 12 may include the disposable housing 20 and thereservoir system 40. The disposable portion of the delivery device 12may be recommended for disposal after a specified number of uses.

On the other hand, elements of the delivery device 12 that do notordinarily contact the body of the user-patient or fluidic media duringoperation of the delivery device 12 may be considered as a durableportion of the delivery device 12. For example, a durable portion of thedelivery device 12 may include the durable housing 30, electronics (notshown in FIG. 2), a drive device having a motor and drive linkage (notshown in FIG. 2), and the like. Elements of the durable housing portionof the delivery device 12 are typically not contaminated from contactwith the user-patient or fluidic media during normal operation of thedelivery device 12 and, thus, may be retained for re-use with replaceddisposable portions of the delivery device 12.

In various embodiments, the disposable housing 20 supports the reservoirsystem 40 and has a bottom surface (facing downward and into the page inFIG. 2) that is configured to secure to the body of a user-patient. Anadhesive may be employed at an interface between the bottom surface ofthe disposable housing 20 and the skin of a user-patient, so as toadhere the disposable housing 20 to the skin of the user-patient. Invarious embodiments, the adhesive may be provided on the bottom surfaceof the disposable housing 20, with a peelable cover layer covering theadhesive material. In this manner, the cover layer may be peeled off toexpose the adhesive material, and the adhesive side of the disposablehousing 20 may be placed against the user-patient, for example againstthe skin of the user-patient. Thus in some embodiments, the deliverydevice 12 may be attached to the skin of the user-patient.

In other embodiments, the disposable housing 20 and/or the remainingportions of the delivery device 12 may be worn or otherwise attached onor underneath clothing of the user-patient. Similarly, the deliverydevice 12 may be supported by any suitable manner, such as, but notlimited to, on a belt, in a pocket, and the like. Representativeexamples of such delivery devices 12 may include, but is not limited to,the MiniMed Paradigm 522 Insulin Pump, MiniMed Paradigm 722 InsulinPump, MiniMed Paradigm 515 Insulin Pump, MiniMed Paradigm 715 InsulinPump, MiniMed Paradigm 512R Insulin Pump, MiniMed Paradigm 712R InsulinPump, MiniMed 508 Insulin Pump, MiniMed 508R Insulin Pump, and any otherderivatives thereof.

The reservoir system 40 is configured for containing or holding fluidicmedia, such as, but not limited to insulin. In various embodiments, thereservoir system 40 includes a hollow interior volume for receivingfluidic media, such as, but not limited to, a cylinder-shaped volume, atubular-shaped volume, or the like. In some embodiments, the reservoirsystem 40 may be provided as a cartridge or canister for containingfluidic media. In various embodiments, the reservoir system 40 is ableto be refilled with fluidic media. In further embodiments, the reservoirsystem 40 is pre-filled with fluidic media.

The reservoir system 40 may be supported by the disposable housing 20 inany suitable manner. For example, the disposable housing 20 may beprovided with projections or struts (not shown), or a trough feature(not shown), for holding the reservoir system 40. In some embodiments,the reservoir system 40 may be supported by the disposable housing 20 ina manner that allows the reservoir system 40 to be removed from thedisposable housing 20 and replaced with another reservoir.Alternatively, or in addition, the reservoir system 40 may be secured tothe disposable housing 20 by a suitable adhesive, a strap, or othercoupling structure.

In various embodiments, the reservoir system 40 includes a port 41 forallowing fluidic media to flow into and/or flow out of the interiorvolume of the reservoir system 40. In some embodiments, the infusionpath 50 includes a connector 56, a tube 54, and a needle apparatus 52.The connector 56 of the infusion path 50 may be connectable to the port41 of the reservoir system 40. In various embodiments, the disposablehousing 20 is configured with an opening near the port 41 of thereservoir system 40 for allowing the connector 56 of the infusion path50 to be selectively connected to and disconnected from the port 41 ofthe reservoir system 40.

In various embodiments, the port 41 of the reservoir system 40 iscovered with or supports a septum (not shown in FIG. 2), such as aself-sealing septum, or the like. The septum may be configured toprevent fluidic media from flowing out of the reservoir system 40through the port 41 when the septum is not pierced. The septum (notshown) may be for inhibiting contamination of the port 41 of thereservoir 40 when the connector 56 of the infusion path 50 isdisconnected from the port 41 of the reservoir 40. Also, in variousembodiments, the connector 56 of the infusion path 50 may include aneedle for piercing the septum (not shown) covering the port 41 of thereservoir system 40 so as to allow fluidic media to flow out of theinterior volume of the reservoir system 40.

Examples of needle/septum connectors can be found in U.S. patentapplication Ser. No. 10/328,393, filed Dec. 22, 2003, entitled“Reservoir Connector,” which is incorporated herein by reference in itsentirety. In other alternatives, non-septum connectors such as Luerlocks, or the like may be used. In various embodiments, the needleapparatus 52 of the infusion path 50 includes a needle that is able topuncture the skin of a user-patient. In addition, in variousembodiments, the tube 54 connects the connector 56 with the needleapparatus 52 and is hollow, such that the infusion path 50 is able toprovide a path to allow for the delivery of fluidic media from thereservoir system 40 to the body of a user-patient.

The durable housing 30 of the delivery device 12 in accordance withvarious embodiments of the present invention includes a housing shellconfigured to mate with and secure to the disposable housing 20. Thedurable housing 30 and the disposable housing 20 may be provided withcorrespondingly shaped grooves, notches, tabs, or other suitablefeatures, that allow the two parts to easily connect together, bymanually pressing the two housings together, by twist or threadedconnection, or other suitable manner of connecting the parts that iswell known in the mechanical arts.

In various embodiments, the durable housing 30 and the disposablehousing 20 may be connected to each other using a twist action. Thedurable housing 30 and the disposable housing 20 may be configured to beseparable from each other when a sufficient force is applied todisconnect the two housings from each other. For example, in someembodiments the disposable housing 20 and the durable housing 30 may besnapped together by friction fitting. In various embodiments, a suitableseal, such as an o-ring seal, may be placed along a peripheral edge ofthe durable housing 30 and/or the disposable housing 20, so as toprovide a seal against water entering between the durable housing 30 andthe disposable housing 20.

The durable housing 30 of the delivery device 12 may support a drivedevice (not shown in FIG. 2), including a motor and a drive devicelinkage portion, for applying a force to fluidic media within thereservoir system 40 to force fluidic media out of the reservoir system40 and into an infusion path, such as the infusion path 50, for deliveryto a user-patient. For example, in some embodiments, an electricallydriven motor may be mounted within the durable housing 30 withappropriate linkage for operatively coupling the motor to a plunger arm(not shown in FIG. 2) connected to a plunger head (not shown in FIG. 2)that is within the reservoir system 40 and to drive the plunger head ina direction to force fluidic media out of the port 41 of the reservoirsystem 40 and to the user-patient.

Also, in some embodiments, the motor may be controllable to reversedirection so as to move the plunger arm and the plunger head to causefluid to be drawn into the reservoir system 40 from a patient. The motormay be arranged within the durable housing 30 and the reservoir system40 may be correspondingly arranged on the disposable housing 20, suchthat the operable engagement of the motor with the plunger head, throughthe appropriate linkage, occurs automatically upon the user-patientconnecting the durable housing 30 with the disposable housing 20 of thedelivery device 12. Further examples of linkage and control structuresmay be found in U.S. patent application Ser. No. 09/813,660, filed Mar.21, 2001, entitled “Control Tabs for Infusion Devices and Methods ofUsing the Same”, which is incorporated herein by reference in itsentirety.

In various embodiments, the durable housing 30 and the disposablehousing 20 may be made of suitably rigid materials that maintain theirshape, yet provide sufficient flexibility and resilience to effectivelyconnect together and disconnect, as described above. The material of thedisposable housing 20 may be selected for suitable compatibility withskin. For example, the disposable housing 20 and the durable housing 30of the delivery device 12 may be made of any suitable plastic, metal,composite material, or the like. The disposable housing 20 may be madeof the same type of material or a different material relative to thedurable housing 30. In some embodiments, the disposable housing 20 andthe durable housing 30 may be manufactured by injection molding or othermolding processes, machining processes, or combinations thereof.

For example, the disposable housing 20 may be made of a relativelyflexible material, such as a flexible silicone, plastic, rubber,synthetic rubber, or the like. By forming the disposable housing 20 of amaterial capable of flexing with the skin of a user-patient, a greaterlevel of user-patient comfort may be achieved when the disposablehousing 20 is secured to the skin of the user-patient. In addition, aflexible disposable housing 20 may result in an increase in site optionson the body of the user-patient at which the disposable housing 20 maybe secured. In some embodiments, the disposable housing 20 may includean adhesive material, as described below, for attaching the disposablehousing 20 to the user-patient or other portions of the medical device,such as, but not limited to, the durable housing 30.

In the embodiment illustrated in FIG. 2, the delivery device 12 isconnected to the sensing device 14 through a connection element 16 ofthe sensing device 14. The sensing device 14 may include a sensor 15that includes any suitable biological or environmental sensing device,depending upon a nature of a treatment to be administered by thedelivery device 12. For example, in the context of delivering insulin toa diabetes patient, the sensor 15 may include a blood glucose sensor, orthe like.

In some embodiments, the sensor 15 may include a continuous glucosesensor. The continuous glucose sensor may be implantable within the bodyof the user-patient. In other embodiments, the continuous glucose sensormay be located externally, for example on the skin of the user-patient,or attached to clothing of the user-patient. In such embodiments, fluidmay be drawn continually from the user-patient and sensed by thecontinuous glucose sensor. In various embodiments, the continuousglucose sensor may be configured to sense and/or communicate with theCCD 16 continuously. In other embodiments, the continuous glucose sensormay be configured to sense and/or communicate with the CCD 16intermittently, for example sense glucose levels and transmitinformation every few minutes. In various embodiments, the continuousglucose sensor may utilize glucose oxidase.

The sensor 15 may be an external sensor that secures to the skin of auser-patient or, in other embodiments, may be an implantable sensor thatis located in an implant site within the body of the user-patient. Infurther alternatives, the sensor may be included with as a part or alongside the infusion cannula and/or needle, such as for example as shown inU.S. patent application Ser. No. 11/149,119, filed Jun. 8, 2005,entitled “Dual Insertion Set”, which is incorporated herein by referencein its entirety. In some embodiments, the sensor 15 may be integratedwith the disposable housing 20. In the illustrated example of FIG. 2,the sensor 15 is an external sensor having a disposable needle pad thatincludes a needle for piercing the skin of the user-patient and enzymesand/or electronics reactive to a biological condition, such as bloodglucose level or the like, of the user-patient. In this manner, thedelivery device 12 may be provided with sensor data from the sensor 15secured to the user-patient at a site remote from the location at whichthe delivery device 12 is secured to the user-patient.

While the embodiment shown in FIG. 2 includes a sensor 15 connected bythe connection element 16 for providing sensor data to sensorelectronics (not shown in FIG. 2) located within the durable housing 30of the delivery device 12, other embodiments may employ a sensor 15located within the delivery device 12. Yet other embodiments may employa sensor 15 having a transmitter for communicating sensor data by awireless communication link with receiver electronics (not shown in FIG.2) located within the durable housing 30 of the delivery device 12. Invarious embodiments, a wireless connection between the sensor 15 and thereceiver electronics within the durable housing 30 of the deliverydevice 12 may include a radio frequency (RF) connection, an opticalconnection, or another suitable wireless communication link. Furtherembodiments need not employ the sensing device 14 and, instead, mayprovide fluidic media delivery functions without the use of sensor data.

As described above, by separating disposable elements of the deliverydevice 12 from durable elements, the disposable elements may be arrangedon the disposable housing 20, while durable elements may be arrangedwithin a separable durable housing 30. In this regard, after aprescribed number of uses of the delivery device 12, the disposablehousing 20 may be separated from the durable housing 30, so that thedisposable housing 20 may be disposed of in a proper manner. The durablehousing 30 may then be mated with a new (un-used) disposable housing 20for further delivery operation with a user-patient.

FIG. 3 illustrates an example of the delivery device 12 in accordancewith another embodiment of the present invention. The delivery device 12of the embodiment of FIG. 3 is similar to the delivery device 12 of theembodiment of FIG. 2. While the delivery device 12 in the embodimentillustrated in FIG. 2 provides for the durable housing 30 to cover thereservoir system 40, the delivery device 12 in the embodiment of FIG. 3provides for the durable housing 30 to secure to the disposable housing20 without covering the reservoir system 40. The delivery device 12 ofthe embodiment illustrated in FIG. 3 includes the disposable housing 20,and the disposable housing 20 in accordance with the embodimentillustrated in FIG. 3 includes a base 21 and a reservoir retainingportion 24. In one embodiment, the base 21 and reservoir retainingportion 24 may be formed as a single, unitary structure.

The base 21 of the disposable housing 20 is configured to be secured tothe body of a user-patient. The reservoir-retaining portion 24 of thedisposable housing 20 is configured to house the reservoir system 40.The reservoir-retaining portion 24 of the disposable housing 20 may beconfigured to have an opening to allow for the port 41 of the reservoirsystem 40 to be accessed from outside of the reservoir-retaining portion24 while the reservoir system 40 is housed in the reservoir-retainingportion 24. The durable housing 30 may be configured to be attachable toand detachable from the base 21 of the disposable housing 20. Thedelivery device 12 in the embodiment illustrated in FIG. 3 includes aplunger arm 60 that is connected to or that is connectable to a plungerhead (not shown in FIG. 3) within the reservoir system 40.

FIG. 4 illustrates another view of the delivery device 12 of theembodiment of FIG. 3. The delivery device 12 of the embodimentillustrated in FIG. 4 includes the disposable housing 20, the durablehousing 30, and the infusion path 50. The disposable housing 20 in theembodiment of FIG. 4 includes the base 21, the reservoir-retainingportion 24, and a peelable cover layer 25. The peelable cover layer 25may cover an adhesive material on the bottom surface 22 of the base 21.The peelable cover layer 25 may be configured to be peelable by auser-patient to expose the adhesive material on the bottom surface 22 ofthe base 21. In some embodiments, there may be multiple adhesive layerson the bottom surface 22 of the base 21 that are separated by peelablelayers.

The infusion path 50 in accordance with the embodiment of the presentinvention illustrated in FIG. 4 includes the needle 58 rather than theconnector 56, the tube 54, and the needle apparatus 52 as shown in theembodiment of FIG. 2. The base 21 of the disposable housing 20 may beprovided with an opening or pierceable wall in alignment with a tip ofthe needle 58, to allow the needle 58 to pass through the base 21 andinto the skin of a user-patient under the base 21, when extended. Inthis manner, the needle 58 may be used to pierce the skin of theuser-patient and deliver fluidic media to the user-patient.

Alternatively, the needle 58 may be extended through a hollow cannula(not shown in FIG. 4), such that upon piercing the skin of theuser-patient with the needle 58, an end of the hollow cannula is guidedthrough the skin of the user-patient by the needle 58. Thereafter, theneedle 58 may be removed, leaving the hollow cannula in place, with oneend of the cannula located within the body of the user-patient and theother end of the cannula in fluid flow connection with fluidic mediawithin the reservoir system 40, to convey pumped infusion media from thereservoir system 40 to the body of the user-patient.

FIG. 5A illustrates a durable portion 8 of the delivery device 12 (referto FIG. 3) in accordance with an embodiment of the present invention.FIG. 5B illustrates a section view of the durable portion 8 inaccordance with an embodiment of the present invention. FIG. 5Cillustrates another section view of the durable portion 8 in accordancewith an embodiment of the present invention. With reference to FIGS. 5A,5B, and 5C, in various embodiments, the durable portion 8 includes thedurable housing 30, and a drive device 80. The drive device 80 includesa motor 84 and a drive device linkage portion 82.

In various embodiments, the durable housing 30 may include an interiorvolume for housing the motor 84, the drive device linkage portion 82,other electronic circuitry, and a power source (not shown in FIGS. 5A,5B, and 5C). In addition, in various embodiments, the durable housing 30is configured with an opening 32 for receiving a plunger arm 60 (referto FIG. 3). In addition, in various embodiments, the durable housing 30may include one or more connection members 34, such as tabs, insertionholes, or the like, for connecting with the base 21 of the disposablehousing 20 (refer to FIG. 3).

FIG. 6A illustrates a disposable portion 9 of the delivery device 12(refer to FIG. 3) in accordance with an embodiment of the presentinvention. FIG. 6B illustrates a section view of the disposable portion9 in accordance with an embodiment of the present invention. FIG. 6Cillustrates another section view of the disposable portion 9 inaccordance with an embodiment of the present invention. With referenceto FIGS. 6A, 6B, and 6C, in various embodiments, the disposable portion9 includes the disposable housing 20, the reservoir system 40, theplunger arm 60, and a plunger head 70. In some embodiments, thedisposable housing 20 includes the base 21 and the reservoir-retainingportion 24. In various embodiments, the base 21 includes a top surface23 having one or more connection members 26, such as tabs, grooves, orthe like, for allowing connections with the one or more connectionmembers 34 of embodiments of the durable housing 30 (refer to FIG. 5B).

In various embodiments, the reservoir system 40 is housed within thereservoir retaining portion 24 of the disposable housing 20, and thereservoir system 40 is configured to hold fluidic media. In addition, invarious embodiments, the plunger head 70 is disposed at least partiallywithin the reservoir system 40 and is moveable within the reservoirsystem 40 to allow fluidic media to fill into the reservoir system 40and to force fluidic media out of the reservoir system 40. In someembodiments, the plunger arm 60 is connected to or is connectable to theplunger head 70.

Also, in some embodiments, a portion of the plunger arm 60 extends tooutside of the reservoir-retaining portion 24 of the disposable housing20. In various embodiments, the plunger arm 60 has a mating portion formating with the drive device linkage portion 82 of the drive device 80(refer to FIG. 5C). With reference to FIGS. 5C and 6C, in someembodiments, the durable housing 30 may be snap fitted onto thedisposable housing 20, whereupon the drive device linkage portion 82automatically engages the mating portion of the plunger arm 60.

When the durable housing 30 and the disposable housing 20 are fittedtogether with the drive device linkage portion 82 engaging or matingwith the plunger arm 60, the motor 84 may be controlled to drive thedrive device linkage portion 82 and, thus, move the plunger arm 60 tocause the plunger head 70 to move within the reservoir system 40. Whenthe interior volume of the reservoir system 40 is filled with fluidicmedia and an infusion path is provided from the reservoir system 40 tothe body of a user-patient, the plunger head 70 may be moved within thereservoir system 40 to force fluidic media from the reservoir system 40and into the infusion path, so as to deliver fluidic media to the bodyof the user-patient.

In various embodiments, once the reservoir system 40 has beensufficiently emptied or otherwise requires replacement, a user-patientmay simply remove the durable housing 30 from the disposable housing 20,and replace the disposable portion 9, including the reservoir system 40,with a new disposable portion having a new reservoir. The durablehousing 30 may be connected to the new disposable housing of the newdisposable portion, and the delivery device including the new disposableportion may be secured to the skin of a user-patient, or otherwiseattached to the user-patient.

In various other embodiments, rather than replacing the entiredisposable portion 9 every time the reservoir system 40 is emptied, thereservoir system 40 may be refilled with fluidic media. In someembodiments, the reservoir system 40 may be refilled while remainingwithin the reservoir retaining portion 24 (refer to FIG. 6B) of thedisposable housing 20. In addition, in various embodiments, thereservoir system 40 may be replaced with a new reservoir (not shown),while the disposable housing 20 may be re-used with the new reservoir.In such embodiments, the new reservoir may be inserted into thedisposable portion 9.

With reference to FIGS. 3, 5A, 6B, and 6C, in various embodiments, thedelivery device 12 includes reservoir status circuitry (not shown), andthe reservoir system 40 includes reservoir circuitry (not shown). Invarious embodiments, the reservoir circuitry stores information such as,but not limited to, at least one of (i) an identification stringidentifying the reservoir system 40; (ii) a manufacturer of thereservoir system 40; (iii) contents of the reservoir system 40; and (iv)an amount of contents in the reservoir system 40. In some embodiments,the delivery device 12 includes the reservoir status circuitry (notshown), and the reservoir status circuitry is configured to read datafrom the reservoir circuitry when the reservoir system 40 is insertedinto the disposable portion 9.

In various embodiments, the reservoir status circuitry is furtherconfigured to store data to the reservoir circuitry after at least someof the contents of the reservoir system 40 have been transferred out ofthe reservoir system 40, so as to update information in the reservoircircuitry related to an amount of contents still remaining in thereservoir system 40. In some embodiments, the reservoir status circuitryis configured to store data to the reservoir circuitry, so as to updateinformation in the reservoir circuitry related to an amount of contentsstill remaining in the reservoir system 40, when the reservoir system 40is inserted into the disposable portion 9. In some embodiments, thedelivery device 12 includes the reservoir status circuitry (not shown)and the reservoir system 40 includes the reservoir circuitry (notshown), and the reservoir status circuitry selectively inhibits use ofthe delivery device 12 or selectively provides a warning signal based oninformation read by the reservoir status circuitry from the reservoircircuitry.

Aspects of the present invention relate, generally, to needle inserteror inserting devices and methods and medical devices, such as, but notlimited to sensors, monitors and infusion medium delivery systems,devices and methods that include such needle-inserting devices andmethods. The needle-inserting device and method may operate to insert aneedle or cannula through skin of a user-patient, for example, toprovide a fluid flow path for conveying an infusion medium through ahollow channel in the needle or cannula and into the user-patient and/orto convey a fluid from the user-patient to one or more sensor elements.Embodiments of the present invention may be configured, as describedherein, to provide a reliable, cost effective, and easy-to-use mechanismfor inserting a needle or cannula to a specific depth into auser-patient with minimal traumatic effect.

In addition, embodiments may be configured to establish a contiguousfluid flow passage for fluid transfer between a reservoir and theuser-patient when the hollow needle or cannula is inserted into theuser-patient. Needle-inserting devices according to embodiments of thepresent invention may be used with, connectable to and disconnectablefrom, or incorporated in a portion of an infusion medium deliverysystem. For example, a needle-inserting device may be connectable to abase structure of a pump-type delivery device for insertion of a needle,after which the needle-inserting device may be removed from the basestructure, whereupon a further housing portion of the delivery device(containing components such as, but not limited to, a reservoir and pumpor drive device) may be coupled to the base structure for operation.Alternatively, the needle-inserting device may be incorporated into thefurther housing portion that contains other components as describedabove. In yet other embodiments, the needle-inserting device may beconnectable to (and releasable from) or incorporated within an injectionsite module or other housing that connects, for example, by flexibletubing, to other components of a medical device (such as, but notlimited to an infusion medium delivery device). In yet otherembodiments, needle inserter devices may be configured for use withsystems other than infusion medium delivery systems, such as, but notlimited to sensor and monitor systems, or the like.

The structure and method described with respect to FIGS. 7-12 may beemployed in any suitable device or system in which two members that, atsome period of time, are not connected in fluid flow communication, areto be connected together in a manner that allows fluid to flow from onemember to the other. In one example embodiment, the structure and methodis described with respect to a first member including a fluid reservoirfor containing an infusion medium that may be connectable to a secondmember including an injection site structure in which a hollow needle orcannula is or may be inserted into a user-patient, for conveying fluidmedia to the user-patient. However, a connection structure according toembodiments of the present invention may be employed to connect any two(or more) members together for fluid flow communication with each other.

In FIGS. 7-12, an example of a structure 100 and method for connectingtwo members in fluid flow communication is described with reference to afirst member 102 and a second member 103. The first member 102 in theillustrated example includes a housing 104 on a base 106. The housing104 may be formed integral with the base 106 or may be formed as aseparate structure that is connected to the base 106 in a fixed relationto the base 106. The housing 104 and base 106 each may be made of anysuitably rigid material, including, but not limited to plastic, metal,ceramic, composite material, or the like.

The housing 104 in the illustrated example includes a section 105containing an injection site structure, in which a hollow needle orcannula may be inserted into a user-patient for conveying fluidic mediato or from the user-patient. In other embodiments, instead of or inaddition to an injection site, the housing 104 may contain, be part of,or be operatively connected to any other suitable structure forconveying, containing, and/or processing fluidic media.

The second member 103 may also include a housing 108, which, in theillustrated embodiment, is a housing of a reservoir for containing aninfusion media. The second member 103 may be held within or otherwise becovered by a further housing member 109 configured to attach to the base106. The further housing 109 may connect to the base 106 of the firstmember 102 by any suitable connection structure. In particularembodiments, at least one of the housing 109 and the base 106 mayinclude one or more flexible pawls, protrusions, indentations, or thelike for engaging and/or receiving one or more corresponding pawls,protrusions, indentations, or the like on the other of the base 106 andthe housing 109, to provide a suitable connection structure.Alternatively or in addition, the connection structure may includeadhesive material or other suitable connectors.

In other embodiments, the housing 108 may be (or be connected to) asensor housing (not shown) that contains sensor components. In yet otherembodiments, the housing 108 may contain, be part of, or be operativelyconnected to any other suitable structure for conveying, containing,and/or processing fluidic media. The housing 108 may be made of anysuitably rigid material, including, but not limited to, plastic, metal,ceramic, composite material, or the like.

The housing 104 may have or (be connected to) a receptacle structure110. The receptacle structure 110 may have an opening 112 in the housingleading into a chamber 114 within the receptacle structure 110. In theillustrated embodiment, the receptacle structure 110 is part of thehousing 104, adjacent the section of the housing 104 that contains theinjection site. In other embodiments, the receptacle structure 110 mayinclude a further housing connected to the housing 104.

The receptacle structure 110 may include a first septum 116 locatedwithin the chamber 114 and may be moveable within the chamber 114 towardand away from the opening 112. The receptacle structure 110 may alsoinclude a bias mechanism 118, which may apply a bias force on the firstseptum 116 in a direction toward the opening 112. The bias mechanism 118may force the first septum 116 against the opening 112, wherein one ormore annular protrusions (or one or more appropriately shaped orpositioned protrusions) 120 adjacent the opening 112 may be provided toinhibit the first septum 116 from being forced out of the chamber 114through the opening 112.

The first septum 116 may have a front surface 116 a that is at leastpartially exposed through the opening 112 when the first septum 116 isurged against the opening 112 by the bias mechanism 118. The firstseptum 116 may have a back surface 116 b facing toward an interior ofthe chamber 114. The first septum 116 may be made of any suitablematerial that may be pierceable by the needle 124, such as, but notlimited to, a natural or synthetic rubber material, silicon, or thelike. In some embodiments, the first septum 116 may be made of aself-sealing material capable of sealing itself after a needle haspierced the first septum 116 and was subsequently withdrawn from thefirst septum 116.

In the illustrated embodiment, the bias mechanism 118 is a coil springlocated within the chamber 114, on the opposite side of the first septum116 with respect to the side of the first septum 116 facing the opening112. In other embodiments, the bias mechanism 118 may be provided byother suitable means for biasing the first septum 116 toward the opening112. These may include, but are not limited to, other types of springs,pressurized fluid within the chamber 114, a collapsible skirt structure122 extending from the first septum 116 with a natural or built-inspring force, chemical, or substance that expands upon contact withanother chemical or substance or upon application of energy from anenergy source such as a heat, laser, or other radiation source, or thelike.

A hollow needle 124 may be supported within the chamber 114. The hollowneedle 124 may have a sharp end 124 a directed toward the back surface116 b of the first septum 116. In the illustrated embodiment, the hollowneedle 124 is supported within the coil spring bias mechanism 118, suchthat its longitudinal axial dimension extends generally parallel to thelongitudinal axial dimension of the coil spring. The hollow needle 124may be supported by a supporting structure 126 located within thereceptacle structure. In the illustrated embodiment, the supportingstructure 126 is a wall integral with the housing of the receptaclestructure 110 and is located on the opposite end of the chamber 114relative to the end of the chamber 114 at which the opening 112 islocated. However, in other embodiments, the supporting structure 126 maybe any suitable structure that is generally fixed relative to thehousing of the receptacle structure 110 and is able to support theneedle 124 in a generally fixed relation to the housing of thereceptacle structure 110.

The hollow needle 124 may be made of any suitably rigid material,including, but not limited to metal, plastic, ceramic, or the like, andmay have a hollow channel that extends in a lengthwise dimension of theneedle 124. The hollow channel in the needle 124 may be open on thesharp end 124 a of the needle 124 and may be open at another location124 b along the length of the needle 124, such as, but not limited to,the needle end that is opposite to the sharp end 124 a. The hollowchannel in the needle 124 may provide a fluid flow path between thesharp end 124 a of the needle 124 and the opening 124 b of the needle124. In the illustrated embodiment, the opening 124 b of the hollowneedle 124 may be connected in fluid flow communication with a manifold128 in a needle injector structure described below.

The housing 108 of the second member 103 may include a connectionportion 130 having a hollow interior chamber 132 and an opening 134 intothe interior chamber 132. A second septum 136 may be supported by thehousing 108 to seal the opening 134. The second septum 136 may besupported in a fixed relation to the housing 108, for example, withinthe housing 108 at one end of the interior chamber 132.

The connection portion 130 of the housing 108 may have a suitable shapeand size to fit at least partially within the opening 112 of thereceptacle structure 110 in the first member 102 when the first andsecond members 102 and 103 are connected together. In the drawings ofFIGS. 7 and 8, the first and second members 102 and 103 are shown in aseparated, disconnected relation, wherein the connection portion 130 ofthe housing 108 is outside of the opening 112 of the receptaclestructure 110. By moving the first and second members 102 and 103together to insert the connection portion 130 into the opening 112 ofthe housing 108, an end surface 138 of the connection portion 130 may beurged against the moveable first septum 116. This may cause the moveablefirst septum 116 to move relative to the housing 108 against the forceof the bias mechanism 118 toward the interior of the chamber 114. As thefirst septum 116 is moved toward the interior of the housing 108, thesharp end 124 a of the needle 124 may pierce the first septum 116.Continued relative movement of the first and second members 102 and 103together may cause the sharp end 124 a of the needle 124 to pass throughthe first septum 116 in the first member 102 and then pierce and passthrough the septum 136 in the second member 103.

When the first and second members 102 and 103 are brought together asdescribed above and as shown in FIG. 9, at least a portion of theconnection portion 130 may extend inside of the housing of thereceptacle structure 110. In addition, the hollow needle 124 (refer toFIG. 8) may pierce the first and second septa 116 and 136 to form afluid flow path between the interior chamber 132 (refer to FIG. 8) ofthe connection portion 130 and the manifold 128 (refer to FIG. 8) (orother structure at the opening 124 b of the needle 124). The receptaclestructure 110 and the connection portion 130 may be provided with matingconnectors that provide, for example, a snap or friction connection uponthe first and second members 102 and 103 being brought together as shownin FIG. 9. In one embodiment, the mating connectors may include aprotrusion (not shown) on one or the other of the receptacle structure110 and the connection portion 130. While the other of the receptaclestructure 110 and the connection portion 130 may include a groove orindentation (not shown) arranged to engage each other in a snap-fittingmanner upon the connection portion 130 being extended into thereceptacle structure 110 a suitable distance.

As mentioned above, in the illustrated embodiment, shown in FIGS. 7-12,the opening 124 b of the needle 124 is connected in fluid flowcommunication with the manifold 128 in an injection site structure. Theinjection site structure may be provided within the section 105 of thehousing 104 and includes a channel 140 extending through the housing 104and the base 106. The channel 140 may have an open end 140 a on a bottomsurface (relative to the orientation shown in FIG. 8) of the base 106.The channel 140 may have another open end 140 b at an upper surface(relative to the orientation shown in FIG. 8) of the section 105 of thehousing 104. The manifold 128 may be located along a length of thechannel 140 and may be in fluid flow communication with the channel 140.Accordingly, the hollow needle 124 may be arranged in fluid flowcommunication with the interior of the channel 140 through the manifold128. The channel 140 may include a channel section 142 having a largerradial dimension relative to the rest of the channel 140 and may have asuitable shape and size to receive a needle and/or cannula, as describedbelow.

A needle-inserting device 144 may be located adjacent the open end 140 bof the channel 140 and arranged to selectively extend a needle and/orcannula into the open end 140 b of the channel 140 and at leastpartially through the channel 140 as described below. Theneedle-inserting device 144 may be configured to be integral with orotherwise fixed to the section 105 of the housing 104 of the firstmember 102. Alternatively, the needle-inserting device 144 may be aseparate device (relative to the housing 104) and may be selectivelyconnected to (in alignment with the channel 140 as shown in FIG. 8) anddisconnected from the section 105 of the housing 104.

In embodiments in which the needle-inserting device 144 is a separatestructure that connects to and disconnects from the housing section 105,a suitable connection structure may be provided on the needle-insertingdevice 144 and the housing section 105 to provide a manually releasableconnection between those components. In such embodiments, the connectionstructure may include, but is not limited to, a threaded extension onone or the other of the needle-inserting device 144 and the housingsection 105 and a corresponding threaded receptacle on the other of thehousing section 105 and the needle-inserting device 144 for receivingthe threaded extension in threaded engagement. In other embodiments,other suitable connection structures may be employed, including, but notlimited to, flexible pawls or extensions on one or the other of theneedle-inserting device 144 and the housing section 105 and acorresponding aperture, stop surface, or the like on the other of theother of the housing section 105 and the needle-inserting device 144.

In the drawing of FIG. 8, the needle-inserting device 144 is shown asconnected to the housing section 105 with a needle 146 and cannula 148in a retracted state. The needle-inserting device 144 may be operated toselectively move the needle 146 and the cannula 148 from the retractedstate (shown in FIG. 8) to an extended state (not shown) in which theneedle 146 and the cannula 148 are extended through the opening 140 b ofthe channel 140 and at least partially through the channel 140, suchthat the sharp end of the needle 146 and at least a portion of thelength of the cannula 148 extend out the opening 140 a of the channel140. Various examples of suitable structure for needle-inserting devicesare described in U.S. patent application Ser. No. 11/645,435, filed Dec.26, 2006, entitled “Infusion Medium Delivery system, Device And MethodWith Needle Inserter And Needle Inserter Device And Method,” which isassigned to the assignee of the present invention and is incorporatedherein by reference, in its entirety. Other examples of suitablestructure for needle-inserting devices are described herein.

The cannula 148 may have a hollow central channel extending along itslongitudinal length and open at one end (the cannula end adjacent thesharp end of the needle 146). The other end of the cannula 148 may havea head 150 having a larger radial dimension than a shaft portion of thecannula 148. The cannula head 150 may have a suitable shape and size tofit into the section 142 of the channel 140, when the needle 146 and thecannula 148 are moved to the extended state by the needle-insertingdevice 144. In particular embodiments, the cannula head 150 may includeone or more protrusions and/or indentations that engage with one or morecorresponding indentations and/or protrusions in the channel section 142of the housing section 105 to provide a friction fit, snap fit, or thelike, to lock or retain the cannula 148 in place within the housingsection 105 upon the needle 146 and cannula 148 being moved to theextended state by the needle-inserting device 144. In furtherembodiments, instead of or in addition to engaging protrusions andindentations, one or more other mechanical structures may be employed toprovide a suitable retaining function for retaining the cannula 148 inplace within the housing section 105 upon the needle 146 and the cannula148 being moved to the extended state by the needle-inserting device144, including, but not limited to, a friction fit structure, snap fit,or the like.

The cannula 148 may have a connection channel 152 provided in fluid flowcommunication with the hollow central channel of the cannula 148. Theconnection channel 152 may be provided, along the longitudinal length ofthe cannula 148, at a location at which the connection channel 152aligns with the manifold 128 (i.e., in fluid flow communication with theinterior of the manifold 128) when the needle 146 and the cannula 148have been moved to the extended state by the needle-inserting device144. In this manner, upon the cannula 148 being moved to the extendedstate, the hollow central channel of the cannula 148 may be arranged influid flow communication with the reservoir 108 through the manifold 128and the connection channel 152.

Thus, according to some embodiments, in operation, a first member 102(which may include, for example, a housing 104 that has a receptacle 110and a injection site section 105) may be coupled together with a secondmember 103 (which may include, for example, a fluid reservoir housing108) by inserting the connection portion 130 of the second member 103into a receptacle 110 of the first member 102. Upon coupling the firstand second members 102 and 103, fluid flow communication may be providedbetween the interior of the second member 103 and the injection sitesection 105 in the first member 102.

In addition, the needle-inserting device 144 may be coupled to theinjection site section 105 of the housing 104 of the first member 102(or is provided as part of a single, unitary structure with theinjection site section 105 of the housing 104). The base 106 of thefirst member 102 may be secured to skin of a user-patient (at a suitableinjection location) with, for example, but not limited to, adhesivematerial as described in U.S. patent application Ser. No. 11/645,435,filed Dec. 26, 2006, entitled “Infusion Medium Delivery system, DeviceAnd Method With Needle Inserter And Needle Inserter Device And Method,”and/or as described herein. Alternatively or in addition, the base 106may be secured to a user-patient by one or more other suitablestructures, including, but not limited to, straps, or the like.

Once the base 106 is suitably secured to the skin of the user-patient ata suitable injection location, the inserting device 144 may be actuatedto move the needle 146 and the cannula 148 from a retracted state (shownin FIG. 8) to an extended state. In the extended state, the needle 146and the cannula 148 may pierce the skin of the user-patient adjacent thebase 106. The cannula 148 may be locked into its extended state byengagement of the cannula head 150 and the channel section 142, asdescribed above. With the cannula 148 locked in the extended state, theneedle 146 may be refracted (for example, by automatic operation of theneedle-inserting device 144 and/or by manual removal of theneedle-inserting device 144 from the housing section 105). Once theneedle 146 is removed, the cannula 148 may be held in place by thehousing section 105, with a portion of the cannula 148 extending intothe user-patient, and with the cannula 148 connected in fluid-flowcommunication with the hollow needle 124. If the first and secondmembers 102 and 103 are connected together, as described above, then afluid-flow connection may be provided from the reservoir 108 to thecannula 148 through the hollow needle 124 and the manifold 128.

The connection sequence (e.g., the sequence of connecting theneedle-inserting device 144 to the injection site section 105 of thehousing 104, connecting the receptacle 110 of the housing 104 to theconnection portion 130 of the reservoir housing 108, and connecting thebase 106 of the first member to the skin of the user-patient) may bedifferent for different embodiments. In one embodiment, a user-patientmay be provided with a first member 102 including the base 106 and thehousing 104 (including injection site section 105) in a pre-connectedstate with the needle-inserting device 144. In this manner, theuser-patient need not have to connect the needle-inserting device 144 tothe housing 104 (as those parts are supplied to the user in apre-connected state, for example, from a manufacturing or assemblyfacility). In that embodiment, the user-patient (or a medicalpractitioner) may secure the base 106 of the first member 102 to his orher skin, at a suitable injection location. After securing the base 106to the skin of the user-patient, the user-patient (or a medicalpractitioner) may activate the needle-inserting device 144 to cause theneedle 146 and the cannula 148 to be moved to the extended state andpierce the skin of the user patient.

After activation of the needle-inserting device 144, theneedle-inserting device 144 may be removed from the housing section 105,leaving the cannula 148 in place within the housing section 105 andpartially extended into the user-patient. With the base 106 of the firstmember 102 secured to the skin of the user-patient and the cannula 148inserted at least partially into the user-patient and arranged influid-flow communication with the hollow needle 124, the second member103 may be connected to the first member 102. In particular, theconnection portion 130 of the housing 108 of the second member 103 maybe inserted into the receptacle 110 of the housing 104 of the firstmember 102 to provide a fluid-flow connection between the interior ofthe housing 108 and the hollow needle 124 and, thus, the cannula 148.Accordingly, the interior of the housing 108, which may be a reservoirhousing, for example, may be coupled in fluid-flow communication withthe cannula 148 that has been extended into a user-patient fordelivering fluid from the reservoir to the user-patient (or forconveying fluid from the user-patient to the reservoir).

While the connection sequence in the above embodiment involves securingthe base 106 of the first member 102 to the user-patient prior toconnection of the second member 103 to the first member 102, in otherembodiments, the second member 103 may be connected to the first member102 (as described above) prior to securing the base 106 of the firstmember onto skin of a user-patient. In such other embodiments, the firstand second members 102 and 103 may be connected together and,thereafter, may be secured to a user-patient by adhering one or both ofthe first and second members 102 and 103 to the skin of theuser-patient. Also, while the connection sequence in the aboveembodiment involves activating the needle-inserting device 144 prior tothe connection of the second member 103 to the first member 102, inother embodiments, the second member 103 may be connected to the firstmember 102 (as described above) prior to activating the needle-insertingdevice 144.

In the embodiment shown in FIGS. 7 and 8, the receptacle 110 is in thefirst member 102 and the connection portion 130 is in the second member103. However, in other embodiments, the receptacle 110 may be in thesecond member 103 (for example, in or associated with a housing for areservoir 108) and the connection portion 130 may be in the first member102 (for example, in or associated with a housing that contains aninjection site structure). Also, in the embodiment shown in FIGS. 7 and8, the receptacle 110 is arranged to allow the connection portion 130 ofthe second member 103 to be inserted in a direction substantiallyparallel to a plane of an upper-facing (in the orientation of FIG. 7)surface of the base 106. In the orientation of FIG. 7, this direction ofinsertion is shown as a horizontal direction of relative motion betweenthe first and second members 102 and 103. However, in other embodiments,the receptacle 110 may be arranged in other suitable orientations,including, but not limited to, an orientation that allows an insertiondirection (relative motion of the first and second members 102 and 103)to be substantially perpendicular to the plane of the upper-facing (inthe orientation of FIG. 7) surface of the base 106. In yet otherembodiments, the receptacle 110 may be arranged to allow any othersuitable insertion direction at an angle transverse to the plane of theupper-facing (in the orientation of FIG. 7) surface of the base 106.

An example arrangement shown in FIGS. 13-16 provides an insertiondirection (relative motion of the first and second members 102 and 103)that is substantially perpendicular to the plane of the upper-facing (inthe orientation of FIG. 8) surface of the base 106. Components in FIGS.13-16 are identified by reference numbers that are the same as referencenumbers used in FIGS. 7-12 for components having similar structure andfunction. In FIGS. 13 and 14, the injection site structure in thehousing 104 is shown in a state after a needle-inserting device has beenoperated to move a cannula 148 to the extended position.

FIGS. 15 and 16 show the base 106 of the first member 102 (of theembodiment of FIGS. 13 and 14) with a needle-inserting device 144attached to the housing 104. The needle-inserting device 144 in FIGS. 15and 16 includes a housing 160 that is securable to the base 106 in anysuitable manner, such as, but not limited to the manners of connectingan inserting device 144 to the housing 105 discussed above with respectto the embodiment of FIGS. 7-12. As shown in FIG. 16, the housing 160contains an internal chamber having a longitudinal dimension L and amoveable plunger 162 located within the housing 160 and moveable alongthe longitudinal dimension L from a retracted position (shown in solidlines in FIG. 16) to an extended position (in which the plunger 162 ismoved to a position E shown in broken lines in FIG. 16).

A bias member 164, such as, but not limited to, a coil spring arrangedwithin the housing 160 maybe configured to impart a bias force on theplunger when the plunger is in the retracted position to urge theplunger 162 toward the extended position E. A locking mechanism (notshown) may be provided such as, but not limited to, a manually moveableprojection, lever, slider, or the like, that is connected to or extendsthrough the housing 160 and engages the plunger 162 (or other structureholding the plunger 162) in a releasable manner, to selectively hold theplunger 162 in its retracted state, against the bias force of the biasmember 164 and to allow a user to selectively release the plunger 162 tomove in the longitudinal direction L under the force of the bias member164.

An insert structure 166 may be arranged within the housing 160 formovement in the longitudinal direction L by action of movement of theplunger 162. The insert structure 166 may include, for example, acup-shaped body 168. The cup-shaped body 168 may hold a first septum 116(similar to the first septum 116 described above with respect to theembodiment of FIGS. 7-12).

A hollow cannula 148 (similar to the cannula 148 described above) mayhave one open end 148 a that may have a sharp tip positioned adjacentthe first septum 116 (or at least partially within the first septum116). The hollow cannula 148 may extend through the cup-shaped body 168and may have a second open end 148 b. The hollow cannula 148 may befixed to the cup-shaped member 168 to move with movement of thecup-shaped member 168. A needle 170 may be secured to the plunger 162and may extend through the first septum 116 and cannula 148 when theplunger 162 is in the retracted position.

In operation, a user-patient (or medical practitioner) may secure thebase 106 to skin of the user-patient (as described above with respect tobase 106 in FIGS. 7-12). Once the base 106 is secured to the skin of theuser-patient, the user-patient (or medical practitioner) may activatethe needle-inserting device 144 to cause the plunger 162 to move fromits retracted state to its extended state and, as a result of suchmovement, to cause the insert structure 166 to be moved into an openinginto the interior of the housing 104. Upon movement of the insertstructure 166 into the housing 104, the insert structure 166 may connectto the base housing 104 by any suitable connection structure.

As discussed above, in particular embodiments, one or the other of thecup-shaped member 168 of the insert structure 166 and the housing 104may include one or more flexible pawls, protrusions, indentations, orthe like, for engaging and receiving one or more corresponding pawls,protrusions, indentations, or the like, on the other of the housing 104and the insert structure 166 to provide a suitable connection structure.Alternatively or in addition, the connection structure may includeadhesive material or other suitable connectors.

In particular embodiments, the housing 160 of the needle-insertingdevice 144 may automatically release from the base 106, upon movement ofthe plunger 162 and the insert structure 166 from the retracted state toan extended state. For example, the housing 160 of the needle-insertingdevice 144 may be made of a material that has sufficient rigidity tooperate as described herein, but also has a suitable flexibility (atleast at the portion of the device 144 that connects to the housing 104)to bend away from and release from the housing 104, upon movement of theinsert structure 166 to the extended state.

As shown in FIG. 16, a portion 172 of the internal surface of thehousing 160 may include a ramped, wedge-shaped, or angled (relative toan axial direction of the housing 144, cannula 148, and needle 170)cross-sectional shape that engages an outer peripheral surface of theinsert structure 166 and/or the plunger 162 as the insert structure 166and plunger 162 are moved toward the extended state. By engaging theangled, ramped, or wedge-shaped portion 172 of the internal surface ofthe housing 160, the plunger 162 and/or the insert structure 166 maycause the wall(s) of the housing 160 to flex outward as the plunger 162and/or insert structure 166 are moved into the extended position. One ormore slots, grooves, or the like 174 may be formed in the housing 166 toenhance the ability of the wall(s) of the housing 160 to flex outward.One or more protrusions 176 and/or indentations may be provided on oneor the other of the interior surface of the housing 166 and the exteriorsurface of the housing 104 for engaging one or more correspondingindentations 178 and/or protrusions in the other of the housing 104 andhousing 166 when the plunger 162 and insert structure 166 are in therefracted state shown in FIG. 16.

The protrusions 176 and indentations 178, when engaged, may lock thehousing 160 of the needle-inserting device 144 to the housing 104. Theone or more protrusions and/or indentations may disengage from eachother when the wall(s) of the housing 160 are flexed outward by themovement of the plunger 162 and the insert structure 166 to the extendedstate. As a result, the housing 160 of the needle-inserting device 144may be automatically disengaged and released from the housing 104 uponmovement of the plunger 162 and insert structure 166 to the extendedstate.

After movement of the plunger 162 and insert structure 166 from theretracted state (shown in FIG. 16) to the extended state (at which theinsert structure 166 may be locked into the housing 104, while thehousing 160 of the needle-inserting device 144 is released from thehousing 104), the bias member 164 (or a second bias member, not shown)may act on the needle 170 to move the needle 170 toward the retractedposition and, thus, withdraw the needle 170 from the cannula 148. Forexample, a return motion of the coil spring after moving from theretracted state to the extended state may provide sufficient force towithdraw the needle 170 from the cannula 148.

Once the insert structure 166 has been locked into place within thehousing 104 and the needle-inserting device 144 has been removed fromthe housing 104, the cannula 148 may be connected in fluid-flowcommunication with a connection portion 130 of a second member (such as,but not limited to a reservoir housing 108), in a manner similar to themanner in which the first and second members 102 and 103 are connectablein the embodiment of FIGS. 7-12. More specifically, the housing 104 mayform a receptacle (similar to the receptacle 110 described above forFIGS. 7-12) and may contain a septum 116 that functions as a firstseptum (similar to the first septum 116 of FIGS. 7-12).

Similar to the embodiment of FIGS. 7-12, the connection portion 130 inFIG. 7 also may also a second septum 136. In particular, the connectionportion 130 may be inserted into the receptacle formed by the housing104 to connect the interior of the reservoir housing 108 in fluid-flowcommunication with the cannula 148. The cannula 148 in FIG. 13 mayinclude a sharp end 148 a adjacent the septum 116. As the connectionportion 130 is inserted into the housing 104, the connection portion maypush the septum 116 against the sharp end 148 a of the cannula 148 tocause the sharp end 148 a of the cannula 148 to pierce the septum 116.Further insertion motion of the connection portion 130 into the housing104 may cause the sharp end 148 a of the cannula 148 to pierce theseptum 136 in the connection portion 130, to form a flow path from or tothe connection portion 130 through the cannula 148.

FIG. 17 illustrates a needle-inserting device 144 according to anembodiment of the present invention. Components in FIG. 17 areidentified by reference numbers that are the same reference numbers usedin FIGS. 7-16 for components having similar structure and function.Similar to the embodiments of FIGS. 7-16, the needle-inserting device144 may also include a plunger 162, a bias member 164, an insertstructure 166, a needle 146, and a cannula 148.

The needle-inserting device 144 in FIG. 17 may include a housing 160that is securable to the base 106 in any suitable manner, such as, butnot limited to the manners of connecting an inserting device 144 to thehousing 105 discussed above with respect to the embodiments of FIGS.7-16. As shown in FIG. 17, the housing 160 may contain an internalchamber having a longitudinal dimension L. The moveable plunger 162 maybe located at least partially within the housing 160 and may be moveablealong the longitudinal dimension L to move the insert structure 166, theneedle 146, and the cannula 148, between at least a retracted position(A in FIG. 17) to an extended position (B in FIG. 17).

The bias member 164, which may be, but is not limited to, a coil springmay be arranged within the housing 160 to impart a bias force on theplunger 162 when the plunger 162 is in a retracted position (A in FIG.17) to urge the plunger 162 along the longitudinal dimension L and movethe insert structure 166, the needle 146, and the needle 148 toward theextended position (B in FIG. 17). In other embodiments, the bias member164 may be provided by other suitable means for imparting a bias forceon the plunger 162. These may include, but are not limited to, othertypes of springs, pressurized fluid within the chamber, a collapsibleskirt structure with a natural or built-in spring force, chemical, orsubstance that expands upon contact with another chemical or substanceor upon application of energy from an energy source such as a heat,laser, or other radiation source, or the like.

A locking mechanism (not shown) may be provided, such as, but notlimited to, a manually moveable projection, lever, slider, or the like,that may be connected to or extends through the housing 160 and engagesthe plunger 162 (or other structure holding the plunger 162) in areleasable manner to selectively hold the plunger 162 in its retractedstate (A in FIG. 17) against the bias force of the bias member 164 andto allow a user to selectively release the plunger 162 to move in thelongitudinal direction L under the force of the bias member 164.

In some embodiments, the locking mechanism (not shown) may be a tab 165connected to an end of the plunger 162. At least a portion of the tab165 and/or the plunger 162 may extend out the housing 160 through anopening 169 in the housing 160. In some embodiments, the tab 165 may beintegral to the plunger 162, while in other embodiments, the tab 165 maybe connected to the plunger 162. The tab 165 may be sized and/orconfigured such that the tab 165 cannot fit through the opening 169 inthe housing 160 and into the internal chamber of the housing 160. Thetab 165 illustrated in FIG. 17 has a diameter slightly larger than adiameter of the opening 169 in the housing 160. As such, the tab 165 isable to selectively hold the plunger 162 in its retracted state (A inFIG. 17) against the bias force of the bias member 164 and to allow auser to selectively release the plunger 162 to move in the longitudinaldirection L under the force of the bias member 164.

To operate the needle-inserting device 144, the user, for example, mayapply force to the tab 165 relative to the plunger 162 and/or housing160 to break the tab 165 away from the plunger 162. This may allow thebias force provided by the bias member 164 to urge the plunger 162 alongthe longitudinal dimension L to move the insert structure 166, theneedle 146, and the needle 148 toward the extended position (B in FIG.17). Although the tab 165 may be configured to be broken away from theplunger 162 and/or housing 160 to free the plunger 162 in someembodiments, alternatively or additionally, the tab 165 may beconfigured to be removable in various ways, such as, but not limited to,by twisting off the tab 165 or pulling off the tab 165.

In other embodiments, the tab 165 and/or the plunger 162 may beconfigured such that the tab 165 can be turned or twisted in a manner toallow the tab 165 to align with and fit through the opening 169 in thehousing 160. In further embodiments, the tab 165 may be made of a rigidmaterial having a slight flexibility. In such embodiments, the tab 165may be able to hold the plunger 162 in its retracted state (A in FIG.17). However, if a user applies a small amount of force or pressure tosqueeze or otherwise compress the tab 165 to a size of comparable sizeand shape as (or smaller than) the opening 169 in the housing 160, thetab 165 and the plunger 165 may be able to advance within the internalchamber of the housing 160 to move the needle 146, the cannula 148, andthe insert structure 166 to the extended position (B in FIG. 17).

In some embodiments, once the plunger 162 is advanced to the extendedposition (B in FIG. 17), the insert structure 166 may connect to thebase housing 104 (FIG. 13) through use of any suitable connectionstructure. In particular embodiments, the insert structure 166 may havea member 168 and the housing 104 may include one or more flexible pawls,protrusions, indentations, or the like, for engaging and receiving oneor more corresponding pawls, protrusions, indentations, or the like, onthe other of the housing 104 and the insert structure 166 to provide asuitable connection structure. Alternatively or in addition, theconnection structure may include adhesive material or other suitableconnectors. FIG. 17 shows the insert structure 166 in the extendedposition (B), and locked into the housing 104 (e.g., after insertion bythe inserting device 144 and after removal of the inserting device 144from the housing 104).

The cannula 148 may have a connection channel 152 provided in fluid-flowcommunication with a central longitudinal channel of the cannula 148.The connection channel 152 may be provided, along the longitudinallength of the cannula 148, and aligned with a fluid channel in fluidcommunication with a reservoir (not shown) containing fluidic media whenthe needle 146 and the cannula 148 have been moved to the extended state(B in FIG. 17) by the needle-inserting device 144. In this manner, uponthe cannula 148 being moved to the extended state, the centrallongitudinal channel of the cannula 148 may be arranged in fluid flowcommunication with the reservoir (not shown), the fluid channel, and theconnection channel 152.

FIGS. 18A and 18B illustrate a medical device 200 in accordance with anembodiment of the present invention. The medical device 200 may include,but is not limited to, a base 201, a structure 202, and at least one ofa cannula 210 and a needle (not shown). The base 201 may be made of anysuitably rigid material, including, but not limited to plastic, metal,ceramic, composite material, or the like. In other embodiments, the base201 may be made of any other suitable material as may be required.

The structure 202 may be connected to and supported by the base 201. Thestructure 202 and the base 201 may be configured for relative movementto each other. For example, the structure 202 and the base 201 may beconfigured such that the structure 202 remains substantially still andthe base 201 is moveable in a case where the medical device 200 ismoved, for instance.

In some embodiments, the base 201 may have an interior area 205containing the structure 202. The base 201 may be removably attachableto a user-patient. For example, the base 201 may have an adhesive layer241 having a certain adhesion strength. The adhesive layer 241 may befor adhering the base 201 to skin 0 or clothing of the user-patient toaffix or otherwise secure the base 201 to the user-patient.

In other embodiments, the structure 202 may be located at any suitablelocation on or along the base 201 that allows the structure 202 and thebase 201 to be connected and allow for relative movement between thestructure 202 and the base 201. For example, the base 201 may have arecess (not shown) or alcove on an edge of the base 201 with thestructure 202 positioned at least partially in the recess (not shown).In yet other embodiments, the structure 202 may be located sufficientlynear the base 201 to allow the structure 202 and the base 201 to beconnected and allow for relative movement between the structure 202 andthe base 201. For example, the structure 202 may be positioned adjacentto an edge of the base 201. In further embodiments, a housing (notshown) may be adapted to install to, cover, or otherwise receive thestructure 202 and the base 201.

For example, the housing (not shown) may be configured to be attachableto one or more of the structure 202 and the base 201. The housing (notshown) may be, for example, installed to the structure 202 and/or thebase 201 prior to one or both of the structure 202 and the base 201being affixed to the user-patient. In some embodiments, the housing (notshown) may be, for example, installed to the structure 202 and/or thebase 201 after one or both of the structure 202 and the base 201 areaffixed to the user-patient.

The structure 202 may include a cannula 210 and/or a needle (not shown),which may be inserted into a user-patient for conveying fluidic media toor from the user-patient. The structure 202 may be removably attachableto the user-patient. For example, the structure 202 may have an adhesivelayer 242 having a certain adhesion strength. The adhesive layer 242 maybe for adhering the structure 202 to skin 0 or clothing of theuser-patient to affix or otherwise secure the structure 202 to theuser-patient.

In some embodiments, the adhesive layer 242 of the structure 202 mayhave an adhesion strength greater than an adhesion strength of theadhesive layer 241 of the base 201. In some embodiments, employing anadhesive layer 242 with the structure 202 with a greater adhesionstrength may allow for the structure 202 and the cannula 210 and/orneedle (not shown) to remain relatively still while attached to the skin0 of the user-patient.

In some embodiments, a first portion of the adhesive layer 242 of thestructure 202 may have an adhesion strength greater than an adhesionstrength of a second portion of the adhesive layer 242 of the structure202. For example, the first portion of the adhesive layer 242 may bealong a periphery of the structure 202, which may allow for strongeradhesion to the user-patient along the periphery or edges of thestructure 202. As another example, the first portion of the adhesivelayer 242 of the structure 202 may be near or adjacent an insertionsite, such as where the cannula 210 and/or needle (not shown) pierce theskin of the user-patient, which may allow for stronger adhesion to theuser-patient at the insertion site.

In some embodiments, a first portion of the adhesive layer 241 of thebase 201 may have an adhesion strength greater than an adhesion strengthof a second portion of the adhesive layer 241 of the base 201. Forexample, the first portion of the adhesive layer 241 may be along aperiphery of the base 201, which may allow for stronger adhesion to theuser-patient along the periphery or edges of the base 201.

The structure 202 may include a channel 214 extending at least partiallythrough the structure 202. The channel 214 may allow a needle (notshown) and/or a cannula (such as 210) to pass through the channel 214when the needle and/or cannula are inserted into the skin 0 of theuser-patient, for example, with a needle insertion device 250 (or 144 asdiscussed with respect to FIGS. 7-17), or as described in variousexamples of suitable structure for needle-inserting devices as describedin U.S. patent application Ser. No. 11/645,435, filed Dec. 26, 2006,entitled “Infusion Medium Delivery system, Device And Method With NeedleInserter And Needle Inserter Device And Method,” which is assigned tothe assignee of the present invention and is incorporated herein byreference, in its entirety.

In addition, the channel 214 may be aligned with the cannula 210 in acase where the cannula 210 is already inserted into the skin 0 of theuser-patient. The channel 214 may be in fluid communication with a fluidconnection 220, which may be in fluid communication with a reservoir(not shown) containing fluidic media. Thus, fluidic media may be able toflow from the reservoir (not shown) through the fluid connection 220into the channel 214 and the cannula 210 to the user-patient.

In some embodiments, the fluid connection 220 may be made of a flexibletubing and may be made of any suitable material for delivering fluidicmedia from the reservoir (not shown) to the user-patient.

The structure 202 illustrated in FIG. 18A may be separate and apart fromthe base 201. There may be a space 243 located between the structure 202and the base 201 to allow for some movement—in an axial direction, alateral direction, or both—of the base 201 relative to the structure202. For example, in a case where the base 201 and the structure 202 areaffixed to the skin 0 of the user-patient and the base 201 is moved orshifted, the base 201 can move laterally and/or latitudinally along thespace 243 provided between the base 201 and the structure 202, asillustrated in FIG. 18B. This may allow the structure 202 attached tothe skin 0 of the user-patient and the cannula 210 and/or needle (notshown) inserted into the skin 0 of the user-patient to remain relativelymotionless to prevent injury to the user-patient or damage to themedical device 200.

With reference to FIGS. 18A and 18B, in other embodiments, the structure202 may be at least partially connected to the base 201. For example,one side of the structure 202 and one side of the base 201 may beconnected or otherwise integral to one another. In further embodiments,the structure 202 and the base 201 may be connected by a living hinge(not shown) or the like, which may be formed for example by injectionmolding with at least one of the base 201 and the structure 202. Infurther embodiments, the living hinge (not shown) may be adapted orconfigured in any suitable manner to release a needle-inserting device250 (discussed later) from the base 201.

In yet other embodiments, the medical device 200 may include a flexibleconnection (e.g., a living hinge) between the structure 202 and the base201. In further embodiments, the flexible connection may be adapted orconfigured in any suitable manner to release a needle-inserting device250 (discussed later) from the base 201. In some embodiments, themedical device 200 may include a bias member (not shown), such as aspring, or the like, located for example in the space 243 providedbetween the base 201 and the structure 202. In such embodiments, thebias member (not shown) may allow for some movement of the base 201relative to the structure 202 while allowing the structure 202 to remainrelatively motionless. In further embodiments, the bias member may beadapted or configured in any suitable manner to release aneedle-inserting device 250 (discussed later) from the base 201.

In some embodiments, at least one of the structure 202, the cannula 210,and the needle (not shown) may be placed or otherwise installed to thebase 201, for example, in the interior area 205 of the base 201, with aneedle-inserting device 250, such as a needle-inserting device asdisclosed with respect to FIGS. 7-17 or other examples of suitableneedle-inserting devices as described in U.S. patent application Ser.No. 11/645,435, filed Dec. 26, 2006, entitled “Infusion Medium Deliverysystem, Device And Method With Needle Inserter And Needle InserterDevice And Method,” which is assigned to the assignee of the presentinvention and is incorporated herein by reference, in its entirety. Infurther embodiments, the needle-inserting device 250 may be configuredto receive at least a portion of the structure 202, for example withtabs 252, or the like.

In various embodiments, the structure 202 may be a sensor (not shown)for sensing a parameter (e.g., physiological parameter) of theuser-patient, such as glucose concentration, temperature, or the like.Thus, in some embodiments, the sensor (not shown) may be arrangedrelative to the base 201 for movement therebetween. The sensor (notshown) may be configured to communicate (e.g., wired electricalcommunication, wireless electrical communication) with at least one ofthe base 201 and/or the medical device 200.

In other embodiments, the sensor (not shown) may be arranged relative tothe structure 202. For example, the sensor (not shown) may be disposedwithin the structure 202 or on an edge of the structure 202. The sensor(not shown) may be operatively connected to (e.g., wired electricalconnection, wireless connection) and supported by the structure 202. Anyof the base 201, the structure 202, and the sensor (not shown) may beconfigured for relative movement to each other. In some embodiments, anyof the base 201, the structure 202, and the sensor (not shown) may beconfigured such that the sensor (not shown) remains substantially stilland the structure 202 and/or the base 201 is moveable in a case wherethe medical device 200 is moved, for instance. In various embodiments,the sensor (not shown) may be placed or otherwise installed to the base201 and/or structure 202 with an insertion device adapted to place orotherwise install the sensor (not shown) to the base 201 and/orstructure 202, similar to needle-inserting device 250.

FIGS. 19A and 19B illustrate a medical device 300 according to anembodiment of the present invention. The medical device 300 may includea base 301 and a needle-inserting device 350. The needle-insertingdevice 350, may be a needle-inserting device as disclosed with respectto FIGS. 7-18B or other various examples of suitable needle-insertingdevices as described in U.S. patent application Ser. No. 11/645,435,filed Dec. 26, 2006, entitled “Infusion Medium Delivery system, DeviceAnd Method With Needle Inserter And Needle Inserter Device And Method,”which is assigned to the assignee of the present invention and isincorporated herein by reference, in its entirety.

The needle-inserting device 350 may include at least one of a needle 355or cannula (not shown). The base 301 may include a top portion 302. Thebase 301 and the top portion 302 may have an opening 305 for insertingat least a portion of the needle-inserting device 350, for example topierce skin 0 of a user-patient of an injection site 315. The opening305 may be directly above the injection site 315 on the skin 0 of theuser-patient, such that the opening 305 is in vertical alignment withthe injection site 315 on the skin 0 of the user-patient. In otherembodiments, such as the embodiment shown in FIG. 20 the opening 306 maybe angled relative to the injection site 315 on the skin 0 of theuser-patient, such that the opening 306 is disaligned with the injectionsite 315 on the skin 0 of the user-patient. In such embodiments, theneedle-inserting device 350 can be inserted, for example, at an angleless than (or greater than) 90 degrees through the opening 306.

With reference to FIGS. 19A and 19B, in some embodiments, the topportion 302 may include a magnifying area 310. The magnifying area 310may magnify or otherwise increase visibility of the injection site 315.This may allow, for example, the user-patient to accurately insert theneedle 355 of the needle-inserting device 350 into his or her skin 0. Assuch, the user-patient may look through the magnifying area 310 to seethe injection site 315 on his or her skin 0 and accordingly insert theneedle-inserting device 350 into the opening 305 and pierce the skin 0with the needle 355. The user-patient may look into the magnifying area310 at any time before, during, and after inserting the needle-insertingdevice 350 into the opening 305. Likewise, the user-patient may lookinto the magnifying area 310 to accurately place the base 301 at aspecific location on his or her skin 0.

Throughout various embodiments, the magnifying area 310 may be locatedat any suitable allow that would allow the user-patient to view theinjection site 315. For example, the magnifying area 310 may be locateddirectly above the injection site 315. In other embodiments, themagnifying area 310 may be offset from the injection site 315. In suchembodiments, the user-patient may view the injection site 315 throughthe magnifying area 310 at an angle. In yet other embodiments, themagnifying area 310 may be located on the needle-inserting device 350,for example at a bottom end, a top end, or a side of theneedle-inserting device 350. In some of those embodiments, themagnifying area 310 of the needle-inserting device 350 may be at leastpartially inserted into the opening 305, in which case the user-patientmay look into the opening 305 to view the injection site 315 through themagnifying area 310 located on the needle-inserting device 350.

The embodiments disclosed herein are to be considered in all respects asillustrative, and not restrictive of the invention. The presentinvention is in no way limited to the embodiments described above.Various modifications and changes may be made to the embodiments withoutdeparting from the spirit and scope of the invention. The scope of theinvention is indicated by the attached claims, rather than theembodiments. Various modifications and changes that come within themeaning and range of equivalency of the claims are intended to be withinthe scope of the invention.

1. A connecting structure for connecting a first member in fluid flowconnection with a second member, the connecting structure comprising: areceptacle structure provided on the first member and having an interiorchamber and an opening into the interior chamber; a first septumprovided within the interior chamber, adjacent the opening of thereceptacle structure; a hollow needle supported within the interiorchamber of the receptacle structure, the hollow needle having a sharpend with a first opening into which fluid may flow, the sharp end facingthe first septum, the hollow needle having a second opening out of whichfluid may flow; a connection portion provided on the second member, theconnection portion having a hollow interior chamber and an opening thatopens to the hollow interior chamber, the connection portion having asize and shape suitable to be inserted at least partially into theopening of the receptacle structure; a second septum supported by theconnection portion of the second member in a position to cover theopening in the connection portion; wherein, upon receiving theconnection portion within the opening of the receptacle structure, theconnection portion pushes the first septum toward the sharp end of thehollow needle, and the sharp end of the hollow needle is caused topierce the first septum and the second septum to come into fluid flowcommunication with the hollow interior chamber of the connectionportion.
 2. A connecting structure as recited in claim 1, wherein: thesecond opening of the hollow needle is provided in fluid flowcommunication with a needle injection site channel; and the needleinjection site channel has an opening that is connectable to an needleinserting device for receiving at least a portion of a needle from theneedle inserting device.
 3. A connecting structure as recited in claim1, further comprising a bias mechanism arranged to apply a bias force onthe first septum directed toward the opening of the receptaclestructure, wherein upon receiving the connection portion within theopening of the receptacle structure, the connection portion pushes thefirst septum toward the sharp end of the hollow needle against the biasforce of the bias mechanism.
 4. A connecting structure as recited inclaim 3, wherein the bias mechanism comprises a coil spring.
 5. Aconnecting structure as recited in claim 3, wherein the bias mechanismcomprises a coil spring and wherein the hollow needle extends throughthe coil spring.
 6. A connecting structure as recited in claim 1,wherein the second member comprises a fluid reservoir and wherein theconnection portion of the second member comprises a portion of the fluidreservoir.
 7. A connecting structure as recited in claim 1, wherein thereceptacle structure is fixed with respect to a base portion and whereinthe connection portion of the second member is provided in a housingthat is connectable to the base portion.
 8. A connecting structure asrecited in claim 2, wherein: the receptacle structure is fixed withrespect to a base portion; the connection portion of the second memberis provided in a housing that is connectable to the base portion; andthe housing includes a recess through which a needle inserting devicemay extend when connected to the opening of the needle injection sitechannel.
 9. A connecting structure as recited in claim 1, wherein theneedle injection site channel has an opening that is connected to aneedle inserting device for receiving at least a portion of a needlefrom the needle inserting device, the needle inserting devicecomprising: a needle inserter housing having an internal chamber and alongitudinal dimension; a plunger arranged for movement within theinternal chamber, in the direction of the longitudinal dimension of theneedle inserter housing, from a first plunger position to a secondplunger position; a plunger bias mechanism for imparting a bias force onthe plunger when the plunger is in the first plunger position, whereinthe bias force is directed toward the second plunger position; a needleconnected to the plunger, for movement with the plunger; a hollowcannula having a hollow interior and arranged with the needle extendingthrough the hollow interior; an insert structure arranged for movementwithin the internal chamber of the needle inserter housing with movementof the plunger from the first plunger position to the second plungerposition; wherein, upon movement of the plunger from the first plungerposition to the second plunger position, the needle, hollow cannula andinsert structure are moved to an insert position with movement of theplunger to the second plunger position.
 10. A connecting structure asrecited in claim 9, wherein the needle inserter housing has least oneslot or groove; and the body of the insert structure includes a shapedportion that is configured to engage the at least one slot or groove,upon the insert structure being moved as the plunger moves from thefirst plunger position to the second plunger position.
 11. A connectingstructure as recited in claim 10, wherein: the needle inserter housinghas a flexible wall portion in the vicinity of the at least one slot orgroove; and the body of the insert structure is arranged to engage andoutwardly flex the flexible wall portion of the needle inserter housing,upon the insert structure being moved as the plunger moves from thefirst plunger position to the second plunger position.
 12. A method ofconnecting a first member in fluid flow connection with a second member,the method comprising: providing a receptacle structure on the firstmember, the receptacle structure having an interior chamber and anopening into the interior chamber; providing a first septum within theinterior chamber, adjacent the opening of the receptacle structure;supporting a hollow needle within the interior chamber of the receptaclestructure, the hollow needle having a sharp end with a first openinginto which fluid may flow, the sharp end facing the first septum, thehollow needle having a second opening out of which fluid may flow;providing a connection portion on the second member, the connectionportion having a hollow interior chamber and an opening that opens tothe hollow interior chamber, the connection portion having a size andshape suitable to be inserted at least partially into the opening of thereceptacle structure; supporting a second septum by the connectionportion of the second member in a position to cover the opening in theconnection portion; and inserting the connection portion within theopening of the receptacle structure, to cause the connection portion topush the first septum toward the sharp end of the hollow needle, tocause the sharp end of the hollow needle to pierce the first septum andthe second septum and come into fluid flow communication with the hollowinterior chamber of the connection portion.
 13. A method as recited inclaim 12, further comprising: providing the second opening of the hollowneedle in fluid flow communication with a needle injection site channel;and providing an opening in the needle injection site channel that isconnectable to an needle inserting device for receiving at least aportion of a needle from the needle inserting device.
 14. A method asrecited in claim 12, further comprising arranging a bias mechanism toapply a bias force on the first septum directed toward the opening ofthe receptacle structure, wherein upon receiving the connection portionwithin the opening of the receptacle structure, the connection portionpushes the first septum toward the sharp end of the hollow needleagainst the bias force of the bias mechanism.
 15. A method as recited inclaim 14, wherein the bias mechanism comprises a coil spring.
 16. Amethod as recited in claim 14, wherein the bias mechanism comprises acoil spring and wherein the method further comprises extending thehollow needle through the coil spring.
 17. A method as recited in claim12, further comprising affixing the receptacle structure to a baseportion and providing the connection portion in a housing that isconnectable to the base portion.
 18. A method as recited in claim 12,further comprising: providing an opening in the needle injection sitechannel; connecting the opening in the needle injection site channel toa needle inserting device for receiving at least a portion of a needlefrom the needle inserting device, the needle inserting devicecomprising: supporting a plunger for movement along a longitudinaldimension of an internal chamber of a housing of the needle insertingdevice, from a first plunger position to a second plunger position;imparting a bias force on the plunger when the plunger is in the firstplunger position, wherein the bias force is directed toward the secondplunger position; supporting a needle on the plunger, for movement withthe plunger; extending the needle through a hollow cannula arranged onthe needle; moving an insert structure within the internal chamber ofthe needle inserter housing with movement of the plunger from the firstplunger position to the second plunger position; wherein, upon movementof the plunger from the first plunger position to the second plungerposition, the needle, hollow cannula and insert structure are moved toan insert position with movement of the plunger to the second plungerposition.
 19. A method as recited in claim 18, wherein providing theneedle inserter housing with at least one slot or groove; and engagingthe at least one slot or groove with a shaped portion of the body of theinsert structure, upon the insert structure being moved as the plungermoves from the first plunger position to the second plunger position.20. A method as recited in claim 19, wherein: providing the needleinserter housing with a flexible wall portion in the vicinity of the atleast one slot or groove; and engaging and outwardly flexing theflexible wall portion of the needle inserter housing with the body ofthe insert structure, upon the insert structure being moved as theplunger moves from the first plunger position to the second plungerposition.